IP Library Granted Patent US 10,828,415
Granted Patent B2
US 10,828,415 · App. 15/737,163 · Granted Nov 10, 2020

Devices, methods, and systems for priming, separating, and collecting blood components

Inventors: Dennis Briggs (West Chester, PA); Simon Do (Pottstown, PA); Eric Rabeno (Lincoln University, PA); Abdoulaye Sangare (Thorndale, PA); Mark Vandlik (West Chester, PA); Vicki Fluck (Quakertown, PA); Christopher Turek (West Chester, PA)
Assignee: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
A61M1/3696A61M1/0209A61M1/3609A61M1/3643A61M1/3644A61M1/3646A61M1/3652A61M1/3683A61M2202/0439A61M2205/051A61M2205/053A61M2205/3331A61M2205/3334A61M2205/6018A61M2230/207G01M3/26
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Quick Facts
Patent No.
US 10,828,415
App. No.
15/737,163
Granted
Nov 10, 2020
Kind
B2
Abstract

A photopheresis system ( 200 ) is disclosed, and that may be configured to execute one or more protocols. These protocols include: 1) protocols ( 400; 430; 460 ) for purging air out of a centrifuge bowl ( 210 ) used by the photopheresis system ( 200 ); 2) protocols ( 500; 510 550 ) for assessing the installation/operation of one or more pressure domes ( 330 ) used by the photopheresis system ( 200 ); and 3) protocols ( 580; 600; 660; 700; 740 ) for collecting buffy coat from blood processed by the photopheresis system ( 200 ).

Claims (38)

1. A method of operating a blood processing system, wherein said blood processing system comprises a deck and a disposable kit, wherein said deck comprises a pressure transducer, wherein at least part of said kit is installed on said deck, wherein said at least part of said kit comprises a pressure dome positioned on said pressure transducer, and wherein said pressure dome comprises a flow chamber, a first flow port for said flow chamber, and a second flow port for said flow chamber, said method comprising:

executing a first negative pressure test on said pressure dome and comprising attempting to generate a first vacuum within said flow chamber by withdrawing fluid out of said flow chamber through one of said first and second flow ports;

executing a first positive pressure test on said pressure dome comprising attempting to generate a first positive pressure within said flow chamber by directing fluid into said flow chamber through one of said first and second flow ports, wherein said first positive pressure test is executed after said first negative pressure test; and

executing a second negative pressure test on said pressure dome comprising attempting to generate a second vacuum within said flow chamber by withdrawing fluid out of said flow chamber through one of said first and second flow ports, wherein said second negative pressure test is executed after said first negative pressure test, and wherein said second vacuum is larger than said first vacuum; and

wherein said first negative pressure test, said first positive pressure test, and said second negative pressure test are each executed by said blood processing system.

2. The method of claim 1 , further comprising:

executing a first assessing step comprising assessing an installation of said pressure dome on said pressure transducer using said first negative pressure test, wherein said first assessing step is executed by said blood processing system.

3. The method of claim 2 , wherein said blood processing system further comprises a display, said method further comprising said blood processing system providing an indication on said display if said first assessing step determines that said pressure dome failed to pass said first negative pressure test.

4. The method of claim 2 , wherein said first assessing step comprises a first determining step, which in turn comprises determining if a pressure within said flow chamber satisfies a first negative pressure threshold.

5. The method of claim 4 , wherein said first determining step comprises using an output of said pressure transducer during said first negative pressure test.

6. The method of claim 4 , wherein satisfying said first negative pressure threshold comprises at least one of said pressure within said flow chamber being between a first negative pressure and a second negative pressure and said first negative pressure threshold comprises said pressure within said flow chamber being of at least a first predetermined amount of vacuum.

7. The method of claim 6 , wherein said first predetermined vacuum is within a range of about −20 mmHg to about −40 mmHG.

8. The method of claim 1 , wherein if said pressure dome does not pass said first negative pressure test, said method further comprises:

reinstalling said pressure dome on said pressure transducer; and

repeating said first negative pressure test.

9. The method of claim 1 , wherein each of said first positive pressure test and said second negative pressure test are executed by said blood processing system only if said blood processing system determines that said pressure dome passed said first negative pressure test.

10. The method of claim 1 , further comprising:

executing a second assessing step comprising assessing an operational range of said pressure transducer using said each of said first positive pressure test and said second negative pressure test.

11. The method of claim 10 , wherein said blood processing system further comprises a display, said method further comprising said blood processing system providing an indication on said display if said second assessing step determines that said pressure dome failed to pass at least one of said first positive pressure test and said second negative pressure test.

12. The method of claim 10 , wherein said second assessing step comprises a second determining step, which in turn comprises determining if a pressure within said flow chamber satisfies a first positive pressure threshold for said first positive pressure test.

13. The method of claim 12 , wherein said second determining step comprises using an output of said pressure transducer during said first positive pressure test.

14. The method of claim 12 , wherein satisfying said first positive pressure threshold comprises at least one of said pressure within said flow chamber being between a first positive pressure and a second positive pressure and said pressure within said flow chamber being of at least a first predetermined amount.

15. The method of claim 12 , wherein satisfying said first positive pressure threshold comprises said pressure within said flow chamber being at least 330 mmHG.

16. The method of claim 10 , wherein said second assessing step further comprises a third determining step, which in turn comprises determining if a pressure within said flow chamber satisfies a second negative pressure threshold for said second negative pressure test.

17. The method of claim 16 , wherein said third determining step comprises using an output of said pressure transducer during said second negative pressure test.

18. The method of claim 16 , wherein satisfying said second negative pressure threshold comprises at least one of said pressure within said flow chamber being between a third negative pressure and a fourth positive pressure and said pressure within said flow chamber being of at least a second predetermined amount of vacuum.

19. The method of claim 16 , wherein satisfying said second negative pressure threshold comprises said pressure within said flow chamber being at a minimum vacuum level of −300 mmHG.

20. The method of claim 1 , wherein said first positive pressure test and said second negative pressure test are executable in any order.

21. The method of claim 1 , wherein said second vacuum is larger than said first vacuum.

22. The method of claim 1 , wherein said pressure dome comprises a flexible diaphragm, wherein an amount of force that said flexible diaphragm exerts on said pressure transducer should change for each of said first negative pressure test, said first positive pressure test, and said second negative pressure test.

23. A method for verifying installation of a pressure dome in a centrifuge system, comprising:

applying a vacuum to a pressure sensor dome at an inlet of a centrifuge using a pump;

determining whether the pump evacuated a volume of air from an area under the pressure sensor dome;

determining a pressure within the pressure sensor dome; and

generating an alert based upon one of: the evacuated volume of air and the determined pressure.

24. The method of claim 23 , wherein upon the volume of air exceeding a threshold amount, the alert corresponds to an indication that the pressure dome is not correctly installed.

25. The method of claim 23 , wherein upon the volume of air not exceeding a threshold volume and the pressure being above a threshold amount, the vacuum continues to be applied.

26. The method of claim 23 , wherein upon pressure being below a threshold amount, the alert corresponds to the pressure dome is installed correctly.

Assignments (21)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2026
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED COMPANY
Reel/Frame 075393/0921 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 23, 2026
From: THERAKOS DEVELOPMENT LIMITED
To: THERAKOS HOLDINGS USA, LLC
Reel/Frame 075227/0886 →
RELEASE OF PATENT SECURITY INTEREST RECORDED AT REEL 69476, FRAME 0380 Recorded Mar 17, 2026
From: NOMURA CORPORATE FUNDING AMERICAS, LLC, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
To: THERAKOS DEVELOPMENT LIMITED
Reel/Frame 075101/0970 →
PATENT SECURITY AGREEMENT Recorded Mar 17, 2026
From: THERAKOS HOLDINGS USA, LLC
To: NOMURA CORPORATE FUNDING AMERICAS, LLC, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
Reel/Frame 075102/0334 →
SECURITY INTEREST Recorded Oct 28, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 073375/0395 →
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
SECURITY INTEREST Recorded Aug 1, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 072331/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 25, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: THERAKOS DEVELOPMENT LIMITED
Reel/Frame 070623/0621 →
RELEASE OF SECURITY INTERESTS Recorded Dec 3, 2024
From: ACQUIOM AGENCY SERVICES, LLC, AS COLLATERAL AGENT
To: MALLINCKRODT PHARMA IP TRADING LIMITED; STRATATECH CORPORATION; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 069476/0103 →
PATENT SECURITY AGREEMENT Recorded Dec 3, 2024
From: SOLARIS IPCO LIMITED
To: NOMURA CORPORATION FUNDING AMERICAS, LLC, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
Reel/Frame 069476/0380 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 17, 2024
From: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 067454/0773 →
CHANGE OF NAME Recorded May 17, 2024
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY
Reel/Frame 067456/0823 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 060434, FRAME 0536 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; VTESSE LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; SUCAMPO PHARMA AMERICAS LLC
Reel/Frame 065601/0347 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 049822, FRAME 0674 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065609/0454 →
SECURITY INTEREST Recorded Nov 15, 2023
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 065595/0376 →
RELEASE OF SECURITY INTERESTS IN PATENTS AT REEL 060389/FRAME 0913 Recorded Nov 15, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0465 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jun 22, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 060434/0536 →
SECURITY INTEREST Recorded Jun 17, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 060389/0913 →
RELEASE OF SECURITY INTEREST Recorded Jun 17, 2022
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS, INC.; MALLINCKRODT LLC; MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY); SPECGX LLC; STRATATECH CORPORATION; VTESSE LLC (F/K/A VTESSE INC.)
Reel/Frame 060389/0839 →
SECURITY INTEREST Recorded Dec 10, 2019
From: MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 051256/0829 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jul 22, 2019
From: MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 049822/0674 →
Continuity (3)
Provisional Application 62288324 · Jan 28, 2016
Provisional Application 62182123 · Jun 19, 2015
Related Publication 20180154066A1 · Jun 7, 2018